Procedural Safety and Device Performance of the Portico (TM) Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry

Mollmann H, Linke A, Nombela-Franco L, Sluka M, Oteo Dominguez JF, Montorfano M, Kim WK, Arnold M, Vasa-Nicotera M, Conradi L, Camuglia A, Bedogni F, Manoharan G (2022)

Publication Type: Journal article

Publication year: 2022

Journal

Journal of Clinical Medicine MDPI

Book Volume: 11

Journal Issue: 16

DOI: 10.3390/jcm11164839

Abstract

A total of 1001 subjects (82.0 years, 62.5% female, 63.7% NYHA III/IV at baseline) with severe aortic stenosis at high surgical risk were enrolled in the prospective CONFIDENCE registry and treated with a Portico (TM) transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNav (TM) DS. The objective of this registry is to characterize the procedural safety and device performance of the Portico (TM) THV at 30 days. The study collected 'standard-of-care' clinical and device performance data, with adverse events adjudicated by an independent clinical event committee according to the Valve Academic Research Consortium-2 criteria. The implantation of a single Portico (TM) THV was successful in 97.5% of subjects. The 30-day all-cause mortality, cardiovascular mortality, and disabling stroke rates were 2.6%, 2.1%, and 1.8%, respectively. A new pacemaker was implanted in 19.0% of subjects at 30 days. At 30 days, the effective orifice area and mean gradient values were 1.82 cm(2) and 7.1 mmHg, respectively. The 30-day rate of moderate paravalvular leak (PVL) was 2.1%, with no occurrence of severe PVL. The Portico (TM) THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the Portico (TM) THV with either the first-generation DS or FlexNav (TM) DS.

Authors with CRIS profile

Martin Arnold Department of Medicine 2 – Cardiology and Angiology

Involved external institutions

St.-Johannes-Hospital DE Germany (DE) Technische Universität Dresden DE Germany (DE) Hospital Clínico San Carlos ES Spain (ES) University Hospital Olomouc / Fakultní Nemocnice Olomouc CZ Czech Republic (CZ) Hospital Universitario Puerta de Hierro - Majadahonda ES Spain (ES) Ospedale San Raffaele (früher: Centro San Raffaele del Monte Tabor Foundation) IT Italy (IT) Kerckhoff-Klinik DE Germany (DE) Universitätsklinikum Frankfurt am Main (KGU) DE Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE) DE Germany (DE) University of Queensland AU Australia (AU) IRCCS Policlinico San Donato IT Italy (IT) Royal Victoria Hospital GB United Kingdom (GB)

How to cite

APA:

Mollmann, H., Linke, A., Nombela-Franco, L., Sluka, M., Oteo Dominguez, J.F., Montorfano, M.,... Manoharan, G. (2022). Procedural Safety and Device Performance of the Portico (TM) Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry. Journal of Clinical Medicine, 11(16). https://doi.org/10.3390/jcm11164839

MLA:

Mollmann, Helge, et al. "Procedural Safety and Device Performance of the Portico (TM) Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry." Journal of Clinical Medicine 11.16 (2022).

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